Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose
mission is to develop medicines that meaningfully improve and
extend the lives of patients facing deadly diseases, today reported
financial results for the fourth quarter and full-year ended
December 31, 2022 and provided an operational update.
“We exited 2022 with a clear focus on our oncology pipeline and
the initiation of the Phase 3 ACTION trial of ONC201 in patients
with H3 K27M-mutant glioma. Patients with this deadly disease are
in desperate need of therapeutic options and ONC201’s robust
foundation of data underscores its potential as a highly
differentiated asset. Following the monetization of TEMBEXA, we
have a strong balance sheet to fully fund Chimerix into 2027,
including through potential approval of ONC201. Recent independent
analyses reported overall survival advantage in patients treated
with ONC201, which has further reinforced our confidence in the
ACTION trial and the commercial opportunity for ONC201,”
said Mike Sherman, Chief Executive Officer
of Chimerix.
“As we look to 2023, we are making tremendous progress and
continuing our strong execution to advance ONC201 towards
regulatory approval. The ACTION trial is enrolling with sites
active in the U.S. and internationally, and we remain on track for
our first data readout in early 2025 with final data readout
expected in 2026. We continue to evaluate emerging data from our
earlier pipeline, including ONC206, which recently demonstrated a
radiographic tumor response in its dose escalation study,”
continued Mr. Sherman.
“The Pacific Pediatric Neuro-oncology Consortium has been
pleased to take a leadership role in the clinical development of
ONC206,” said Sabine Mueller, MD, PhD, MAS, Professor of Neurology,
Neurosurgery and Pediatrics, University of California San Francisco
(UCSF) and clinical lead of the Diffuse Midline Glioma Center in
Zurich Switzerland. “We are very excited about the potential for
ONC206 to treat brain cancers more broadly, beyond those with the
H3K27M-mutation. To observe a monotherapy response in a recurrent
glioblastoma patient without the H3K27M-mutation is quite exciting.
The fact that this occurred with a dose level at the low end of the
range has added to our enthusiasm as we continue to dose
escalate.”
ONC201 for Treatment of H3 K27M-Mutant Diffuse
Glioma
In November 2022, Chimerix initiated the Phase 3 ACTION study, a
randomized, double-blind, placebo-controlled, multicenter
international study of ONC201 in newly diagnosed diffuse glioma
patients whose tumor harbors an H3 K27M-mutation. Treatment with
ONC201 will begin shortly after completion of radiation therapy.
The study is designed to enroll 450 patients randomized 1:1:1 to
receive ONC201 at one of two dosing frequencies or placebo.
Participants will be randomized to receive 625mg of ONC201 once per
week (the Phase 2 dosing regimen), 625mg twice per week on two
consecutive days or placebo. The dose will be scaled by body weight
for pediatric patients. Overall survival (OS) will be assessed for
efficacy at three alpha-allocated timepoints: two interim
assessments by the Independent Data Monitoring Committee (IDMC) at
164 events and 246 events, respectively, and a final assessment at
327 events. The final Progression Free Survival analysis will be
performed after 286 events, with progression assessed using RANO
HGG criteria by blinded independent central review (BICR).
Ongoing Development of ONC206
ONC206 is a second generation imipridone that has demonstrated
anti-cancer activity in pre-clinical models of various central
nervous system (CNS) tumors and other malignancies. ONC206 is a
ClpP agonist and DRD2 antagonist with enhanced in vitro potency
relative to ONC201. ONC206 is currently being evaluated in Phase 1
dose escalation clinical trials for adults with recurrent primary
central nervous system tumors at the National Institutes of Health
(NIH) and in pediatric CNS tumors with the Pacific Pediatric
Neuro-Oncology Consortium (PNOC). Preclinical and early clinical
observations in initial low dose cohorts suggest that ONC206 may be
effective for CNS tumors beyond those that harbor the H3 K27M
mutation addressed by ONC201.
An investigator- assessed response in a recurrent glioblastoma
patient without the H3K27M-mutation who received monotherapy ONC206
has emerged during dose escalation in the PNOC study.
The unmet need in glioblastoma is extraordinarily high with over
25,000 newly diagnosed patients in the United States and Europe
annually. Dose escalation will continue, and results are expected
to be reported at a future scientific conference.
Fourth Quarter 2022 Financial Results
Chimerix's balance sheet at December 31,
2022 included $266.0 million of capital available to
fund operations, no debt, and approximately 88.1 million
outstanding shares of common stock.
Chimerix reported a net loss of $21.0 million, or $0.24 per
basic and diluted share, for the fourth quarter of 2022, compared
to a net loss of $39.5 million, or $0.45 per basic and diluted
share for the fourth quarter of 2021.
Research and development expenses decreased to $19.3 million for
the three-month period ended December 31, 2022, compared to $34.3
million for the same period in 2021.
General and administrative expenses increased to $5.3 million
for the fourth quarter of 2022, compared to $5.2 million for the
same period in 2021.
Full Year 2022 Financial Results
Chimerix reported a net income of $172.2 million, or $1.97 per
basic and $1.94 per diluted share, for the year ended December 31,
2022. For the year ended December 31, 2021, Chimerix recorded a net
loss of $173.2 million, or $2.04 per basic and diluted share. The
increase was primarily driven by the sale of TEMBEXA to Emergent
BioSolutions.
Revenues for 2022 increased to $33.8 million, compared to $2.0
million in 2021.
Research and development expenses decreased to $71.6 million for
the year ended December 31, 2022, compared to $73.8 million for the
year ended December 31, 2021.
General and administrative expenses increased to $22.1 million
for the year ended December 31, 2022, compared to $18.7 million for
the year ended December 31, 2021.
Conference Call and Webcast
Chimerix will host a conference call and live audio webcast to
discuss fourth quarter and full-year 2022 financial results and
provide a business update today at 8:30 a.m. ET. To access the live
conference call, please dial 646-307-1963 (domestic) or
800-715-9871 (international) at least five minutes prior to the
start time and refer to conference ID 9730865.
A live audio webcast of the call will also be available on the
Investors section of Chimerix’s website, www.chimerix.com. An
archived webcast will be available on the Chimerix website
approximately two hours after the event.
About Chimerix
Chimerix is a biopharmaceutical company with a mission to
develop medicines that meaningfully improve and extend the lives of
patients facing deadly diseases. The Company’s most advanced
clinical-stage development program, ONC201, is in development for
H3 K27M-mutant glioma.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 that are subject
to risks and uncertainties that could cause actual results to
differ materially from those projected. Forward-looking statements
include those relating to, among other things, the probability of
success of the Phase 3 ACTION study, the potential approval of and
commercial opportunity for ONC201, the implications of the
monotherapy radiographic partial response observed during ONC206
dose escalation, and projections regarding funding and future data
readouts. Among the factors and risks that could cause actual
results to differ materially from those indicated in the
forward-looking statements are risks related to the timing,
completion and outcome of the Phase 3 ACTION study of ONC201; risks
associated with the availability of accelerated approval for
ONC201; risks related to the clinical development of ONC206; and
additional risks set forth in the Company's filings with
the Securities and Exchange Commission. These forward-looking
statements represent the Company's judgment as of the date of this
release. The Company disclaims, however, any intent or obligation
to update these forward-looking statements.
CONTACTS: Michelle
LaSpaluto919 972-7115ir@chimerix.com Will O’ConnorStern
Investor Relations212-362-1200will@sternir.com Nick
Lamplough / Dan Moore / Tanner KaufmanJoele
Frank, Wilkinson Brimmer Katcher(212) 355-4449
|
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CHIMERIX,
INC. |
|
CONSOLIDATED
BALANCE SHEETS |
|
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
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|
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|
December
31, |
|
December
31, |
|
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
25,842 |
|
|
$ |
15,397 |
|
|
|
Short-term investments, available-for-sale |
|
|
191,492 |
|
|
|
72,970 |
|
|
|
Accounts receivable |
|
|
1,040 |
|
|
|
- |
|
|
|
Inventories |
|
|
- |
|
|
|
2,760 |
|
|
|
Prepaid expenses and other current assets |
|
|
9,764 |
|
|
|
4,678 |
|
|
|
|
Total current assets |
|
|
228,138 |
|
|
|
95,805 |
|
|
Long-term investments |
|
|
48,626 |
|
|
|
2,022 |
|
|
Property and equipment, net of accumulated depreciation |
|
|
227 |
|
|
|
253 |
|
|
Operating lease right-of-use assets |
|
|
1,964 |
|
|
|
2,404 |
|
|
Other long-term assets |
|
|
386 |
|
|
|
56 |
|
|
|
|
|
Total
assets |
|
$ |
279,341 |
|
|
$ |
100,540 |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,034 |
|
|
$ |
2,788 |
|
|
|
Accrued liabilities |
|
|
17,381 |
|
|
|
13,108 |
|
|
|
Note payable |
|
|
- |
|
|
|
14,000 |
|
|
|
|
Total current liabilities |
|
|
20,415 |
|
|
|
29,896 |
|
|
Loan Fees |
|
|
250 |
|
|
|
- |
|
|
Lease-related obligations |
|
|
1,819 |
|
|
|
2,392 |
|
|
|
|
|
Total
liabilities |
|
|
22,484 |
|
|
|
32,288 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock, $0.001 par value, 10,000,000 shares authorized at
December 31, 2022 and |
|
|
|
|
|
|
2021; no shares issued and outstanding as of December 31, 2022 and
2021 |
|
|
- |
|
|
|
- |
|
|
|
Common stock, $0.001 par value, 200,000,000 shares authorized at
December 31, 2022 and |
|
|
|
|
|
2021; 88,054,127 and 86,884,266 shares issued and outstanding as of
December 31, 2022 |
|
|
|
|
|
and 2021, respectively |
|
|
88 |
|
|
|
87 |
|
|
|
Additional paid-in capital |
|
|
970,535 |
|
|
|
953,782 |
|
|
|
Accumulated other comprehensive loss, net |
|
|
(337 |
) |
|
|
(21 |
) |
|
|
Accumulated deficit |
|
|
(713,429 |
) |
|
|
(885,596 |
) |
|
|
|
Total stockholders’ equity |
|
|
256,857 |
|
|
|
68,252 |
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
279,341 |
|
|
$ |
100,540 |
|
|
|
|
|
|
|
|
|
|
|
CHIMERIX,
INC. |
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS)
INCOME |
|
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
Procurement revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
31,971 |
|
|
$ |
- |
|
|
|
Contract and grant revenue |
|
|
439 |
|
|
|
- |
|
|
|
942 |
|
|
|
1,928 |
|
|
|
Licensing revenue |
|
|
- |
|
|
|
46 |
|
|
|
536 |
|
|
|
51 |
|
|
|
Royalty revenue |
|
|
375 |
|
|
|
- |
|
|
|
375 |
|
|
|
- |
|
|
|
|
Total revenues |
|
|
814 |
|
|
|
46 |
|
|
|
33,824 |
|
|
|
1,979 |
|
|
|
Cost of goods sold |
|
|
- |
|
|
|
- |
|
|
|
447 |
|
|
|
- |
|
|
|
|
Gross Profit |
|
|
814 |
|
|
|
46 |
|
|
|
33,377 |
|
|
|
1,979 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
19,281 |
|
|
|
34,337 |
|
|
|
71,631 |
|
|
|
73,817 |
|
|
|
General and administrative |
|
|
5,347 |
|
|
|
5,241 |
|
|
|
22,132 |
|
|
|
18,672 |
|
|
|
Acquired in-process research and development |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
82,890 |
|
|
|
|
Total operating expenses |
|
|
24,628 |
|
|
|
39,578 |
|
|
|
93,763 |
|
|
|
175,379 |
|
|
|
|
|
Loss from operations |
|
|
(23,814 |
) |
|
|
(39,532 |
) |
|
|
(60,386 |
) |
|
|
(173,400 |
) |
|
Other (loss) income: |
|
|
|
|
|
|
|
|
|
|
Interest income and other, net |
|
|
2,737 |
|
|
|
34 |
|
|
|
2,919 |
|
|
|
164 |
|
|
|
Gain on sale of business, net |
|
|
- |
|
|
|
- |
|
|
|
229,670 |
|
|
|
- |
|
|
|
|
|
|
(Loss) income before income taxes |
|
|
(21,077 |
) |
|
|
(39,498 |
) |
|
|
172,203 |
|
|
|
(173,236 |
) |
|
|
Income tax expense |
|
|
(117 |
) |
|
|
- |
|
|
|
36 |
|
|
|
- |
|
|
|
|
|
|
Net
(loss) income |
|
|
(20,960 |
) |
|
|
(39,498 |
) |
|
|
172,167 |
|
|
|
(173,236 |
) |
|
Other comprehensive (loss) income: |
|
|
|
|
|
|
|
|
|
|
Unrealized loss on investments, net |
|
|
(300 |
) |
|
|
(21 |
) |
|
|
(316 |
) |
|
|
(21 |
) |
|
|
|
|
|
Comprehensive (loss) income |
|
$ |
(21,260 |
) |
|
$ |
(39,519 |
) |
|
$ |
171,851 |
|
|
$ |
(173,257 |
) |
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
Net (loss) income, basic |
|
$ |
(0.24 |
) |
|
$ |
(0.45 |
) |
|
$ |
1.97 |
|
|
$ |
(2.04 |
) |
|
|
Net (loss) income, diluted |
|
$ |
(0.24 |
) |
|
$ |
(0.45 |
) |
|
$ |
1.94 |
|
|
$ |
(2.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic |
|
|
88,049,138 |
|
|
|
86,867,070 |
|
|
|
87,555,110 |
|
|
|
84,930,255 |
|
|
|
Weighted-average shares outstanding, diluted |
|
|
88,049,138 |
|
|
|
86,867,070 |
|
|
|
88,776,147 |
|
|
|
84,930,255 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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